- Hologic (Newark, DE)
- …from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part ... 820, MDD 93/42/EEC, EU MDR, and MDSAP. + Familiarity with reliability modeling and testing for electro-mechanical devices and capital equipment. + Expertise in design inputs/requirements analysis, design verification/validation, and design transfer processes.… more
- Hologic (Newark, DE)
- …global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. + Expertise in Software Development Life Cycle (SDLC) ... Agile/iterative design controls. + Advanced knowledge of risk management frameworks ( ISO 14971), including hazard analysis and FMEA. + Familiarity with usability… more
- Amentum (Anchorage, AK)
- …of experience in progressively more responsible EHS and/or Quality role. + Introduction to ISO 9001 QMS Training a plus + ISO 9001QMS Internal Auditor Training ... a plus + Six-Sigma Greenbelt a plus. + Knowledge of database development and maintenance. + Working knowledge of EHS training practices, metrics, and programs. + Working knowledge of applicable OSHA regulations. + Ability to understand, collate and interpret… more
- Hologic (Marlborough, MA)
- …**Knowledge:** + Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 (Risk Management), and EU MDR (Regulation 2017/745). ... + Advanced understanding of medical device standards, including usability, reliability, electrical safety, and software regulations. + Thorough knowledge of design control processes, verification and validation planning, and requirements traceability. +… more
- CBRE Government and Defense Services (San Antonio, TX)
- …systems, critical thinking skills, and proficiency with standard testing tools. + * ISO Lead Auditor Certification with a thorough understanding of ISO 9001:2015 ... standards + * Knowledge of recognized and generally accepted good engineering practice regulations and codes. + Excellent analytical and computer skills, specifically in MS Office Suite. + Strong written and oral communication and presentation skills. + Strong… more
- Teleflex (Mansfield, MA)
- …medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired * Experience in Lean/Six Sigma techniques ... suppliers. "Hands-on" approach towards manufacturing floor involvement. * Experience with GDP, and ISO Quality Systems, is strongly desired * Ability to work in fast… more
- Ford Motor Company (Palo Alto, CA)
- …FTA, HARA) to derive stringent safety requirements and ensure functional safety ( ISO 26262). You'll have - Bachelor's or master's degree in electrical engineering, ... practices. - Understanding and practical application of automotive functional safety standards (eg, ISO 26262). You may not check every box, or your experience may… more
- Hatch (Pittsburgh, PA)
- …experience + Windows Azure servers + Knowledge of BIM principles, with emphasis on ISO 19650 and ISO 15926 + Experience working directly on projects in ... a multi-disciplinary engineering environment. + Expert user in MicroStation and AutoCAD + Programming Experience: APIs (RESTful APIs and OpenAPI), Power BI, Python Why join us? + Work withgreat people (https://bit.ly/36124ja) to make a difference + Collaborate… more
- UGI Corporation (King Of Prussia, PA)
- …diverse organizational structures. + Experience using various frameworks such as NIST, ISO /IEC 27000, NERC-CIP, FAIR, CSA, COBIT, COSO, OCTAVE, PCI 27000 series, ... structures. + Experience using various risk management frameworks such as NIST, ISO /IEC 27000, FISMA, FAIR, CSA, COBIT, COSO, OCTAVE, PCI 27000 series, ITIL,… more
- ThermoFisher Scientific (St. Paul, MN)
- …Guarantee adherence to quality standards and regulatory requirements during the qualification process ( ISO 9001 Quality system with many aspects of ISO 13485 ... included). Work with interdisciplinary teams and departments in various countries to achieve the best possible outcomes and ensure a global consistency between our products manufactured in our various locations. Lead and support cross functional product… more